U.S. patent application number 11/829001 was filed with the patent office on 2008-01-31 for vascular access device volume displacement.
This patent application is currently assigned to BECTON, DICKINSON AND COMPANY. Invention is credited to Chad M. Adams, Kelly D. Christensen, Christopher N. Cindrich, Weston F. Harding, Frank Holloway, S. Ray Isaacson, Austin Jason McKinnon.
Application Number | 20080027398 11/829001 |
Document ID | / |
Family ID | 38982370 |
Filed Date | 2008-01-31 |
United States Patent
Application |
20080027398 |
Kind Code |
A1 |
McKinnon; Austin Jason ; et
al. |
January 31, 2008 |
VASCULAR ACCESS DEVICE VOLUME DISPLACEMENT
Abstract
A medical device includes a vascular access device with an
access port having a septum and a slit. The slit is formed on the
inner surface of the body of the septum where the access port
receives an access device that is separate from the vascular access
device through the slit of the septum. A pivoting member in
communication with the access port pivots when the port is accessed
by an access device. The medical device may be used to control the
volume displacement of a chamber within the medical device by
decreasing the volume of the chamber by inserting a substance
having a mass into the chamber, pivoting a structure associated
with the chamber, and increasing the volume of the chamber
simultaneously and commensurately with the mass of the substance
inserted into the chamber.
Inventors: |
McKinnon; Austin Jason;
(Herriman, UT) ; Harding; Weston F.; (Lehi,
UT) ; Cindrich; Christopher N.; (Draper, UT) ;
Christensen; Kelly D.; (Centerville, UT) ; Isaacson;
S. Ray; (Roy, UT) ; Adams; Chad M.; (West
Jordan, UT) ; Holloway; Frank; (Loveland,
CO) |
Correspondence
Address: |
David W. Highet;Becton, Dickinson and Company
(Metcalf Intellectual Property Law, LLC), 1 Becton Drive, MC 110
Franklin Lakes
NJ
07417-1880
US
|
Assignee: |
BECTON, DICKINSON AND
COMPANY
Franklin Lakes
NJ
|
Family ID: |
38982370 |
Appl. No.: |
11/829001 |
Filed: |
July 26, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60820639 |
Jul 28, 2006 |
|
|
|
Current U.S.
Class: |
604/264 |
Current CPC
Class: |
A61M 2039/263 20130101;
A61M 2039/266 20130101; A61M 2039/261 20130101; A61M 39/045
20130101; A61M 39/26 20130101 |
Class at
Publication: |
604/264 |
International
Class: |
A61M 5/14 20060101
A61M005/14 |
Claims
1. A medical device, comprising: a vascular access device with an
access port having a septum and a slit, wherein the slit is formed
on the inner surface of a body of the septum, and wherein the
access port receives an access device that is separate from the
vascular access device through the slit of the septum; and a
pivoting member in communication with the access port, wherein the
pivoting member pivots when the port is accessed by an access
device such that upon removal of the access device fluid is not
drawn into the medical device.
2. The medical device of claim 1, wherein the pivoting member is a
T-bone shaped rigid structure.
3. The medical device of claim 1, wherein the pivoting member is an
L-shaped rigid structure.
4. The medical device of claim 1, wherein the pivoting member is a
rib.
5. The medical device of claim 1, wherein the pivoting member is a
wedge.
6. The medical device of claim 1, wherein the pivoting member is a
gate held under the tension of a torsion spring.
7. The medical device of claim 1, wherein the pivoting member
articulates upon a bistable spring.
8. The medical device of claim 1, wherein the pivoting member forms
a curved structure.
9. The medical device of claim 1, wherein the pivoting member is a
four-bar mechanism.
10. The medical device of claim 1, wherein the pivoting member is a
semi-rigid buckling member.
11. The medical device of claim 1, wherein the pivoting member is a
rigid member displaced by a disturbed air pressure chamber.
12. The medical device of claim 1, wherein the pivoting member is a
spring finger.
13. The medical device of claim 1, wherein the pivoting member is a
split wedge.
14. A method of controlling volume displacement in a chamber of a
medical device, comprising: decreasing the volume of a chamber of
an extravascular system by inserting a substance having a mass into
the chamber, pivoting a rigid structure within the extravascular
system, and increasing the volume of the chamber simultaneously and
commensurately with the mass of the substance inserted into the
chamber.
15. The method of claim 14, wherein the substance is a mechanical
structure of a medical device.
16. The method of claim 15, wherein the mechanical structure is a
tip of a syringe.
17. The method of claim 14, wherein the substance is a fluid.
18. The method of claim 14, wherein the rigid structure comprises a
T-bone shaped rigid structure.
19. The method of claim 14, wherein the rigid structure comprises
an L-shaped rigid structure.
20. The method of claim 14, wherein the rigid structure comprises a
rib.
21. The method of claim 14, wherein the rigid structure comprises a
wedge.
22. A medical device, comprising: a pivoting means for increasing
the volume of a chamber in an extravascular system upon actuation
of the medical device, wherein the pivoting means for increasing
the volume communicates commensurately with a means for decreasing
the volume of the chamber.
23. The medical device of claim 22, wherein the means for
increasing the volume is housed within a closed Luer access
device.
24. The medical device of claim 22, wherein the pivoting means is a
T-bone shaped rigid structure.
25. The medical device of claim 22, wherein the pivoting means is
an L-shaped rigid structure.
26. The medical device of claim 22, wherein the pivoting means is a
rib.
27. The medical device of claim 22, wherein the pivoting means is a
wedge.
28. The medical device of claim 22, wherein the pivoting means is a
gate held under the tension of a torsion spring.
29. The medical device of claim 22, wherein the pivoting means
articulates upon a bistable spring.
30. The medical device of claim 22, wherein the pivoting means
forms a curved structure.
31. The medical device of claim 1, wherein the pivoting means is a
four-bar mechanism.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/820,639, filed Jul. 28, 2006, entitled VASCULAR
ACCESS DEVICE VOLUME DISPLACEMENT, which is incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] The present disclosure relates to the displacement of volume
in medical devices such as vascular access devices to provide
infusion or other therapy to patients. Infusion therapy is one of
the most common health care procedures. Hospitalized, home care,
and other patients receive fluids, pharmaceuticals, and blood
products via a vascular access device inserted into the vascular
system. Infusion therapy may be used to treat an infection, provide
anesthesia or analgesia, provide nutritional support, treat
cancerous growths, maintain blood pressure and heart rhythm, or
many other clinically significant uses.
[0003] Infusion therapy is facilitated by vascular access devices
located outside the vascular system of a patient (extravascular
devices). Extravascular devices that may access a patient's
peripheral or central vasculature, either directly or indirectly,
include closed access devices, such as the BD Q-SYTET.TM. closed
Luer access device of Becton, Dickinson and Company; syringes;
split access devices; catheters; and intravenous (IV) fluid
chambers. A vascular access device may be indwelling for short term
(days), moderate term (weeks), or long term (months to years). A
vascular access device may be used for continuous infusion therapy
or for intermittent therapy.
[0004] A common vascular access device is a plastic catheter that
is inserted into a patient's vein. The catheter length may vary
from a few centimeters for peripheral access to many centimeters
for central access. The catheter may be inserted transcutaneously
or may be surgically implanted beneath the patient's skin. The
catheter, or any other extravascular device attached thereto, may
have a single lumen or multiple lumens for infusion of many fluids
simultaneously.
[0005] The proximal end of a vascular access device commonly
includes a Luer adapter to which other medical devices may be
attached. For example, an administration set may be attached to a
vascular access device at one end and an IV bag at the other. The
administration set is a fluid conduit for the continuous infusion
of fluids and pharmaceuticals. Commonly, an TV access device is a
vascular access device that may be attached to another vascular
access device, closes or seals the vascular access device, and
allows for intermittent infusion or injection of fluids and
pharmaceuticals. An IV access device may comprise a housing and a
septum for closing the system. The septum may be opened with a
blunt cannula or a male Luer of a medical device.
[0006] Complications associated with infusion therapy may cause
significant morbidity and even mortality. One significant
complication is catheter related blood stream infection (CRBSI). An
estimate of 250,000-400,000 cases of central venous catheter (CVC)
associated BSIs occur annually in US hospitals. Attributable
mortality is an estimated 12%-25% for each infection and a cost to
the health care system of $25,000-$56,000 per episode.
[0007] Vascular access device infection resulting in CRBSIs may be
caused by pathogens entering the fluid flow path from refluxed or
displaced blood subsequent to catheter insertion. Studies have
shown the risk of CRBSI increases with catheter indwelling periods.
This may be due, at least in part, to the reflux or displacement of
blood from the vascular system of a patient to an extravascular
device, such as the catheter. When contaminated, pathogens adhere
to the vascular access device, colonize, and form a biofilm. The
biofilm is resistant to most biocidal agents and provides a
replenishing source for pathogens to enter a patient's bloodstream
and cause a BSI.
[0008] Certain extravascular devices can operate with each other to
form a continuous, extravascular system that provides fluid access
to the vascular system, yet is entirely sealed from the external
surrounding environment. Such a sealed system limits or supposedly
prevents unwanted bacteria from entering from the external
surrounding environment through the extravascular devices to the
vascular system of a patient.
[0009] However, a sealed system of extravascular devices
(extravascular system) may function as a closed or sealed vacuum,
capable of drawing blood, and consequently a culture for infection,
into the extravascular system. As devices are twisted off or
otherwise removed from the extravascular system, the volume of the
extravascular system is sometimes slightly increased. Because
extravascular systems are often less elastic than a patient's
vascular system, when the volume of the extravascular system is
increased, the volume of a patient's vascular system is decreased
under a vacuum pressure from the extravascular system. When the
volume of the vascular system decreases, blood flows or is sucked
from the vascular system to the extravascular system. Further, as
pressure in the extravascular system decreases below the vascular
pressure of a patient, either as a result of a change in volume in
the extravascular system or another event, blood will flow from the
vascular system to the extravascular system.
[0010] As recognized in conjunction with the present invention,
even a temporary presence of blood within an extravascular system
can cause future operational challenges for that extravascular
system. For example, blood that clots in the end of a catheter of
an extravascular system can block future fluid flow between the
extravascular system and a vascular system. If drugs and other
fluid substances are forced through the extravascular system
causing the blood clot to dislodge from the extravascular system,
the blood clot will enter the vascular system causing a dangerous
embolism within the patient. Finally, as discussed above, even the
rapid entry and exit of blood into the catheter tip of an
extravascular system will leave a residue of protein, bacteria, and
other pathogens on the inner wall of the catheter. This residue may
become a breeding ground for bacteria to grow, and after a given
period of time, will cause the formation of a harmful biofilm that
is difficult to remove or bypass during extravascular system
operation.
[0011] Therefore, a need exists for systems and methods that avoid
or limit the reflux or displacement of blood from a patient's
vascular system into an extravascular system that is connected to
the patient's vascular system.
BRIEF SUMMARY OF THE INVENTION
[0012] The present invention has been developed in response to
problems and needs in the art that have not yet been fully resolved
by currently available extravascular systems, devices, and methods.
Thus, these developed systems, devices, and methods provide an
extravascular system that may be connected to a patient's vascular
system and will limit or prevent the flow, reflux, or displacement
of blood from the vascular system to the extravascular system.
[0013] A medical device may include a vascular access device with
an access port having a septum and a slit. The slit is formed on
the inner surface of the body of the septum. The access port may
receive an access device that is separate from the vascular access
device through the slit of the septum. A pivoting member in
communication with the access port pivots when the port is accessed
by an access device.
[0014] The pivoting member may be one of the following types of
devices: a T-bone shaped rigid structure, a T-bone shaped rigid
structure on the outer surface of the septum, an L-shaped rigid
structure, a gate held under the tension of a torsion spring, a
rib, a wedge, a split wedge, a four-bar mechanism, a semi-rigid or
rigid buckling member, a rigid member displaced by a disturbed air
pressure chamber, a rigid member displaced by a disturbed pressure
sensitive chemical, and/or a spring finger. The pivoting member may
articulate upon a bistable spring, a torsion spring, or other
spring or tension creating member. The pivoting member may form a
curved or other structure.
[0015] A method of employing the medical device may be used to
control the volume displacement within a chamber of the medical
device. The method may include decreasing the volume of a chamber
of an extravascular system by inserting a substance having a mass
into the chamber, pivoting a structure within the extravascular
system, and increasing the volume of the chamber simultaneously and
commensurately with the mass of the substance inserted into the
chamber. The substance may be either a fluid or a mechanical
structure of a medical device, such as the tip of a syringe.
[0016] These and other features and advantages of the present
invention may be incorporated into certain embodiments of the
invention and will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter. The present invention
does not require that all the advantageous features and all the
advantages described herein be incorporated into every embodiment
of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0017] In order that the manner in which the above-recited and
other features and advantages of the invention are obtained will be
readily understood, a more particular description of the invention
briefly described above will be rendered by reference to specific
embodiments thereof which are illustrated in the appended drawings.
These drawings depict only typical embodiments of the invention and
are not therefore to be considered to limit the scope of the
invention.
[0018] FIG. 1 is a perspective view of an extravascular system
connected to the vascular system of a patient.
[0019] FIG. 2 is a cross section view of a vascular access device
with pivoting T-bone members.
[0020] FIG. 3 is a cross section view of the vascular access device
of FIG. 2 taken along lines 3-3
[0021] FIG. 4 is a cross section view of the vascular access device
of FIG. 2 shown with the tip of a separate device inserted.
[0022] FIG. 5 is a cross section view of the vascular access device
of FIG. 4 taken along lines 5-5.
[0023] FIG. 6 is a cross section view of a vascular access device
having an alternative embodiment of a pivoting member.
[0024] FIG. 7 is a cross section view of a vascular access device
having a further embodiment of a pivoting member.
[0025] FIG. 8 is a partial cross section view of a vascular access
device with an external pivoting member.
[0026] FIG. 9 is a cross section view of a vascular access device
with a bistable spring pivoting member
[0027] FIG. 10 is a partial cross section view of the vascular
access device of FIG. 9 with the bistable spring pivoting member
actuated in an open position.
[0028] FIG. 11 is a partial cross section view of a vascular access
device with a rigid pivoting member.
[0029] FIG. 12 is a partial cross section view of the vascular
access device of FIG. 11 with the tip of a separate device
inserted.
[0030] FIG. 13 is a partial cross section view of a vascular access
device with a rigid pivoting member.
[0031] FIG. 14 is a partial cross section view of the vascular
access device of FIG. 13 with the tip of a separate device
inserted.
[0032] FIG. 15 is a partial cross section view of a vascular access
device and closed spring loaded valve.
[0033] FIG. 16 is a partial cross section view of the vascular
access device of FIG. 15 with the spring loaded valve open.
[0034] FIG. 17 is a partial cross section view of a vascular access
device with a spring loaded valve.
[0035] FIG. 18 is a partial cross section view of a vascular access
device having a rigid member.
[0036] FIG. 19 is a partial cross section view of the vascular
access device of FIG. 18 with the tip of a separate device
inserted.
[0037] FIG. 20 is a partial cross section view of a vascular access
device and a rotational clip.
[0038] FIG. 20A is a partial cross section view of the vascular
access device illustrated in FIG. 20 with a separate device
inserted.
[0039] FIG. 21 is a perspective view of a vascular access
device.
[0040] FIG. 22 is a perspective view of a vascular access device
including the septum with a reservoir.
[0041] FIG. 23 is a perspective view an annular member with spring
fingers.
[0042] FIG. 24 is a cross section view of a vascular access device
with a collapsed reservoir.
[0043] FIG. 25 is a cross section view of the vascular access
device of FIG. 24 showing the reservoir full.
[0044] FIG. 26 is a partial cross section view of a vascular access
device with a split wedge.
[0045] FIG. 27 is a partial cross section view of the vascular
access device of FIG. 26 with the split wedge in open position.
[0046] FIG. 28 is a partial cross section view of a vascular access
device with two curved pivoting members.
[0047] FIG. 29 is a partial cross section view of the vascular
access device of FIG. 28 the tip of a separate device inserted.
[0048] FIG. 30 is a partial cross section view of a vascular access
device with a four-bar mechanism.
[0049] FIG. 31 is a partial cross section view of the vascular
access device of FIG. 30 with the tip of a separate device
inserted.
[0050] FIG. 32 is a cross section view of a vascular access device
with a rigid member.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The presently preferred embodiments of the present invention
will be best understood by reference to the drawings, wherein like
reference numbers indicate identical or functionally similar
elements. It will be readily understood that the components of the
present invention, as generally described and illustrated in the
figures herein, could be arranged and designed in a wide variety of
different configurations. Thus, the following more detailed
description, as represented in the figures, is not intended to
limit the scope of the invention as claimed, but is merely
representative of presently preferred embodiments of the
invention.
[0052] Referring now to FIG. 1, a vascular access device (also
referred to as an extravascular device, intravenous access device,
and/or access port) 10 is used to introduce a substance via a
catheter 12 across the skin 14 and into a blood vessel 16 of a
patient 18. The vascular access device 10 includes a body 20 with a
lumen and a septum 22 placed within the lumen. The septum 22 has a
slit 24 through which a separate extravascular device 26, such as a
syringe, may introduce a substance into the vascular access device
10.
[0053] The device 10 also includes a member (discussed with
reference to the figures below) capable of creating a volume within
the vascular access device 10 and/or the extravascular system 28 to
which the vascular access device 10 is connected. The member
capable of creating this volume creates the volume when a tip 30 of
the separate device 26 is inserted into the vascular access device
10 through the slit 24 of the septum 22. Normally, when the tip 30
is inserted into the device 10, the volume of the extravascular
system 28 is decreased, causing fluid to flow from the system 28
into the blood vessel 16. Conversely, under normal conditions, when
the tip 30 is removed from the device 10, the volume of the
extravascular system 28 is increased, causing blood to flow from
the blood vessel 16 into the system 28 by entering through the end
32 of the catheter 12.
[0054] As mentioned throughout this description, even a temporary
presence of blood within an extravascular system 28 can cause
future operational challenges for that extravascular system 28.
These problems may include blood clots, fluid flow barriers,
embolisms, and the production of harmful biofilm. Thus, the devices
disclosed herein are provided to avoid reflux or drawback of blood
from the blood vessel 16 into the catheter 12. The devices may
include a member capable of creating a volume when the separate
device 26 is inserted into the vascular access device 10 and will
permit the created volume to decrease to its original size. When
the volume decreases to its original size, the decrease in volume
will offset any volume displaced such that upon removal of the
separate access device 26. The volume offset will either result in
no net displacement of fluid between the system 28 and the vessel
16 or will result in fluid being forced distally from the vascular
access device 10 or other medical device toward the vascular system
of a patient. This further avoids creation of a vacuum or a
pressure differential between the system 28 and the vessel 16 that
would cause blood to flow or be sucked from the blood vessel 16
into the catheter 12.
[0055] Referring now to FIG. 2, a vascular access device 10
includes at least one rigid, pivoting member 34 within the wall of
the septum 22. The pivoting member 34 is rigid in relation to the
materials of its surrounding environment. In this embodiment, the
septum 22 is formed of silastic or other pliable, elastic material.
Thus, the pivoting member 34 may be formed of hardened rubber,
plastic, metal, alloy, or other relatively rigid material. The
pivoting member 34 is shaped as a T-bone structure with a first end
36 of the top of the "IT" extending towards the slit 24 of the
septum. A second end 38 of the top of the "T" extends towards the
edge of the body 20 of the vascular access device 10. The base 40
of the "T" extends into a separation of an outer chamber 42 and an
interior chamber 44 of the device 10.
[0056] FIG. 3 is a cross-section view of the vascular access device
10 of FIG. 2 taken along lines 3-3. Device 10 includes the base 40
of the "T" of the pivoting member 34 embedded within a silastic
material. This silastic material is an extension of the septum 22
and has been manufactured, extruded, molded, heat-treated, or
otherwise formed to include at least one fold 46 along its cross
section. The fold 46 remains until a separate device 26 is placed
within the slit 24 of the septum 22 causing the rigid member 34 to
open. When the rigid member 34 opens, the base members 40 move from
a first resting position shown in FIG. 3 to a second opened
position to be shown in FIG. 5. When the base members 40 are moved
from a first resting position to a second opened position, the at
least one fold 46 straightens causing the volume of the outer
chamber 42 to decrease and the volume of the interior chamber 44 to
increase.
[0057] Referring now to FIG. 4, a vascular access device 10 of FIG.
2 is shown with the tip 30 of the separate device 26 inserted
within the septum 22. As the tip 30 is inserted into the septum,
the walls of the septum begin to move downward and outward in a
direction 48. As the walls of the septum 22 are moved in a
direction 48 under the influence of the tip 30, rigid members 34
pivot outward causing the first ends 36 to move downward and the
base members 40 to move outward towards the body 20 of the vascular
access device 10.
[0058] The first ends 36 move downward, away from the direction of
the advancing tip 30 as the second ends 38 pivot against a fulcrum
50 placed within the body 20 of the vascular access device 10. As
the base members 40 are moved outwards towards the body 20 of the
device 10, the volume of the outer chamber 42 decreases while the
volume of the interior chamber 44 increases. At least one channel
52 may need to be placed within the body 20 of the vascular access
device 10 in order to permit the air within the outer chamber 42 to
escape the outer chamber 42 when the base members 40 are moved into
the space of the outer chamber 42. The at least one channel 52 will
permit the volume of the outer chamber 42 to decrease without any
pressure buildup that would require an increase in insertion force
during tip 30 insertion.
[0059] FIG. 5 is a cross-section taken along lines 5-5 of FIG. 4.
The vascular access device 10 includes the base member 40 extended
towards the body 20 of the vascular access device 10. With the base
members 40 extended, the silastic material no longer includes at
least one fold 46. Rather the folds 46, as show in FIG. 3, have
been extended to form a straight section of the silastic member
such that the volume of the outer chamber 42 has been decreased and
the volume of the interior chamber 44 has been increased.
[0060] When the tip 30 of a separate device 26 is removed from the
slit 24 of the septum 22, the rigid member 34 closes under the
force of the formed silastic material that is an extension of the
septum 22. As mentioned earlier with reference to FIG. 3, the
silastic material has been manufactured or otherwise formed to
include at least one fold (FIG. 3) along its cross-section. These
folds 46 exist when the silastic material is in its resting
position. Thus, when the silastic material is stretched as shown in
FIG. 5, once the tip 30 of the separate device 26 is removed, the
natural force of the formed silastic material will cause the
silastic material to return to its original position as shown in
FIG. 3. When the formed silastic material returns to its original
position, the base members 40 will likewise return to its original
position causing the volume of the outer chamber 42 to increase
while the volume of the interior chamber 44 decreases. This
decrease of volume within the interior chamber 44 will result in
either no net volume displacement within the interior chamber 44 or
will result in a volume that is displaced from the interior chamber
44 downstream through the extravascular system 28 and into the
vascular system of a patient.
[0061] Referring now to FIG. 6, a vascular access device 210
includes at least one rigid, pivoting member 234 within the wall of
the septum 222. The pivoting member 234 is rigid in relation to the
materials of its surrounding environment. As with embodiments
previously discussed, the septum 222 is formed of silastic or other
pliable, elastic material. Thus, the pivoting member 234 may be
formed of hardened rubber, plastic, metal, alloy, or other
relatively rigid material. The L-shaped member may be encased in
the silastic as illustrated in FIG. 6, or may be bonded or attached
to the silastic by means well known to those of skill in the
art.
[0062] In this embodiment, the pivoting member 234 is shaped as an
L-shaped structure with a first end 236 of the top of the "L"
extending towards the slit 224 of the septum. The base 240 of the
"L" extends downwardly along the channel through the septum 210.
Thus, when a separate extravascular device 26 is inserted into the
septum, the rigid L-shaped pivoting member 234 causes the channel
238 through the septum to increase in volume. When the
extravascular device 26 is removed and the channel 238 returns to
its original configuration, the volume within the channel 238 is
reduce, thus preventing blood or other fluid from being drawn up
into the extravascular system 28.
[0063] FIG. 7 illustrates an alternative embodiment of the device
in which the L-shape pivoting member 234 is replaced by a rigid
wedge member 250. Wedge member 250 can be made of rigid plastic or
other similar materials. Once again, wedge member 250 provides
sufficient rigidity to cause the channel 230 to expand in volume as
a separate extravascular device 26 is inserted into the device 210.
Thus, when the extravascular device 26 is removed, the volume
decreases to its original state, preventing blood or other fluids
from being drawn into the extravascular system 28.
[0064] Referring now to FIG. 8, a partial cross-section view of a
vascular access device 10 shows a rigid, folding member 54 located
on the external surface of a silastic septum 56. The silastic
septum 56 includes a knob 58 on its exterior surface to which the
pivoting member 54 is attached. The pivoting member 54 also
includes an elbow 60 housed within a fulcrum 62 of the body 20 of
the vascular access device 10. The elbow 60 houses a flap 64 that
extends from the body 20 of the septum 56. In use, when a separate
device 26 is placed within the slit 24 of the septum 56, the body
20 of the septum 56 is biased downward and outward in a direction
48, causing the knob 58 and/or any portion of the entire structure
of the pivoting member 54 to bias downward and outward in the
direction 48. As the pivoting member 54 pivots in the direction 48,
the volume of the interior chamber 44 is increased while the volume
of the outer chamber is decreased.
[0065] Referring now to FIG. 9, a vascular access device 10
includes a rigid, pivoting member 66 embedded within the material
of a silastic septum 22. The pivoting member 66 includes a bistable
spring 68 along the top of the "T" of the pivoting member 66.
[0066] FIG. 10 is a partial cross section view of the device 10 of
FIG. 9. As illustrated in FIG. 10, the bistable spring 68 of the
pivoting member 66 is a beam that snaps open after a predetermined
amount of pressure has been applied to the bistable spring 68. In
use, as the tip 30 of a separate device 26 is advanced through the
slit 24 of the septum 22, the septum 22 begins to open in an
outward direction causing pressure to build upon the bistable
spring 68. After a given amount of pressure has been placed on the
bistable spring 68, the beam of the bistable spring 68 will snap
open causing the pivoting member 66 to pivot upon a fulcrum 70 of
the body 20, which in turn causes the base 72 of the pivoting
member 66 to move downward and outward in a direction 48. When the
base member 72 of the pivoting member 66 moves toward the body 20,
the volume of the interior chamber 44 is increased and the volume
of the outer chamber 42 is decreased.
[0067] A bistable spring may be used with any of the above
illustrated embodiments or with any of a number of the following
embodiments described throughout this detailed description. The
properties of the bistable spring may preferably be employed when a
rapid increase in volume within an interior chamber is desired when
a separate device 26 is introduced into the vascular access device
10. Similarly, the properties of the bistable spring may also
preferably be employed when a rapid decrease in volume of an
interior chamber is desired upon retraction and/or removal of a
separate device 26 from the vascular access device 10.
[0068] In some embodiments, a gradual increase in volume of an
interior chamber may be desired as a separate device is gradually
inserted into the slit of the septum of the device. In these
embodiments, as the separate device is gradually inserted, the
opening of the septum decreases the volume of the interior chamber,
while the opening of a rigid member simultaneously increases the
volume of the interior chamber, offsetting the decrease of volume
caused by the insertion of the separate device. In this manner,
during the initial entry of the separate device into the septum,
all the way through full engagement and full removal of the
separate device from the septum, there will be no net change in
volume of the interior chamber. Thus, with no net change in volume
of the interior chamber during use of the vascular access device,
any potential displacement of fluid into and out of a patient's
vascular system is avoided.
[0069] Referring now to FIG. 11, a vascular access device 10
includes at least one rigid member 74 in the shape of a wedge
placed below the slit 24 of a septum 22 when the device 10 is in a
resting state.
[0070] Referring now to FIG. 12, when the tip 30 of a separate
device 26 is inserted into the septum 22, the rigid members 74 are
biased downward and outward in a direction 48 causing an increase
in volume within an interior chamber 44. The increased volume of
interior chamber 44 is illustrated as volume 76. The rigid members
74 may be embedded, or surrounded, by an elastic material, such as
silastic. The silastic may be attached at an elbow 78 of the
silastic to a fulcrum 80 of the body 20 of the vascular access
device 10. A lower portion 82 of the elastic material will stretch
to enable the rigid member 74 to create the additional volume 76
when the tip 30 is inserted into the septum 22.
[0071] Referring now to FIG. 13, a vascular access device 10
includes a rigid member 84 such as a rigid rib having a structure
that is continuous with a silastic or other elastic septum 22 and
an elastomer 86. The elastomer 86 is attached to the base of the
rib 84 while the septum 22 is attached to the head of the rib 84.
The rib or rigid member 84 may also be embedded or otherwise
attached to a continuous elastomer as illustrated throughout the
embodiments of this detailed description. As mentioned earlier, one
end of the elastomer 86 is attached to the rib 84, while the other
end of the elastomer is fixed at a point 88 within the vascular
access device 10. Because the elastomer 86 is fixed at a point 88
and attached to the base of the rib 84, when the rib 84 pivots,
causing the elastomer 86 to stretch, the elastomer 86 will not be
dislodged from its fixed point 88.
[0072] Referring now to FIG. 14, the vascular access device 10 of
FIG. 13 shows the tip 30 of an external device 26 inserted within
the septum 22. As the tip 30 advances through the septum 22, the
rigid members 84 pivot upon an elbow 90 that communicates with a
fulcrum 92 of the body 20 of the vascular access device 10. When
the rigid members 84 pivot, the base of the rigid members 84 moves
in an outward direction 94 stretching the elastomer 86 and creating
an increased amount of volume 96 within the interior chamber 44.
When the tip 30 of the external device 26 is removed from the
septum 22, the pivoting members 84 return to their original resting
position as shown in FIG. 13, causing the elastomers 86 to return
to their original position and the volume gained 96 to be decreased
to an original volume of the interior chamber 44. A similar
decrease in volume occurs with reference to FIGS. 11 and 12 when
the tip 30 is removed from the device 10 of that particular
embodiment.
[0073] Referring now to FIG. 15, a vascular access device 10
includes a septum 98 that is sealed by a rigid, pivoting member 100
which pivots on a torsion type spring 102. The tension of the
spring 102 biases the pivoting member 100 in a clockwise direction
104. In its resting state, the pivoting member 100 seals the septum
98 in a closed position.
[0074] Referring now to FIG. 16, the vascular access device 10 of
FIG. 15 is shown with the tip 30 of a separate device 26 inserted
into the septum 98. The tip 30 is shown discharging a fluid 106
towards the pivoting member 100. The force of the fluid 106 and/or
the force of the mechanical insertion of the tip 30 against a lower
wing 108 of the pivoting member 100 causes the pivoting member 100
to rotate in a counter clockwise direction against the tension of
the torsion spring 102. When the pivoting member 100 rotates
counter clockwise, the lower wing 108 extends into the interior
chamber 44 and the upper wing 110 of the pivoting member 100
retracts into a cavity within the wall of the septum 98 to create
an increased volume 112. After the fluid 106 has been fully
discharged into the interior chamber 44 and the rate of flow has
decreased and/or after the tip 30 is removed, the tension of the
torsion spring 102 will cause the pivoting member 100 to rotate
again clockwise to a position that seals the septum 98 as shown in
FIG. 15. Once sealed, the pivoting member 100 prevents any backflow
of fluid 106 into the septum chamber where the tip 30 is
inserted.
[0075] Referring now to FIG. 17, a vascular access device 10
includes a septum 112 and a pivoting member 114 placed under
tension of a torsion spring 116. When fluid is infused and/or the
tip 30 of a separate device 26 is inserted into the septum 112, the
pivoting member 114 rotates counter clockwise against the clockwise
tension of the torsion spring 116. When the pivoting member 114
rotates counter clockwise, a lower wing 118 moves into an interior
chamber 44 to decrease the volume of the interior chamber 44.
Simultaneously, an upper wing 120 is retracted from the interior
chamber 44 into a recess of the septum 112 to create a larger
volume 122 within the interior chamber 44.
[0076] Thus, the vascular access device 10 of FIG. 17 is an
alternate embodiment to the vascular access device of FIGS. 15 and
16 which creates more volume than the volume that is used or
depleted when the tip 30 accesses the device 10. The increased
volume 122 is possible because the upper wing 120 is longer than
the lower wing 118, and when the pivoting member 114 rotates
counter clockwise a greater amount of volume is created than the
amount of volume that is depleted.
[0077] The embodiments shown in FIGS. 15 through 17 thus reveal a
pivoting member that creates a larger volume within an interior
chamber 44 when the pivoting member is activated by the insertion
of the tip 30 of a separate, external device 26. Preferably, the
length of the various wings and the tension placed on the torsion
spring of the pivoting member of the embodiments of FIG. 15 through
17, may be adjusted to ultimately produce a mechanically activated
valve that avoids any reflux or displacement of fluid. In this
manner, the tip 30 of a separate device 26 may be inserted into the
vascular access device 10, fluid may be discharged, and a patient
may be treated without the operation of the extravascular system
ever resulting in fluid traveling upstream, i.e., from a patient's
vascular system to a catheter of the extravascular system.
[0078] Referring now to FIG. 18, a vascular access device 10
includes an elastomeric septum 124 with a rigid spring and pivoting
member 126 embedded in the base 128 of the septum 124. The base 128
of the septum 124 rests upon a fulcrum or pivot point 130. The
device 10 also includes a channel 132 located between the pivot
point and the body 20 of the device 10.
[0079] Referring now to FIG. 19, the vascular access device 10 of
FIG. 18 is shown with the tip 30 of a separate device 26 inserted
into the septum 124. With the tip 30 fully inserted into the septum
124, the rigid spring member 126 is forced to bend or otherwise
buckle in order to create a cavity 134 in which fluid is stored.
The fluid enters the created cavity 134 through the flow channel
132 as the rigid spring member 126 is bent in an upward arched
shape. As the tip 30 is removed from the septum 124, the pressure
placed on the spring member 126 is removed causing the spring
member 126 to return to its original position as shown in FIG. 18.
When the spring member 126 returns to its original position, the
cavity 134 disappears as the fluid that was once stored within the
cavity 134 travels through the flow channel 132 and into the
interior chamber 44.
[0080] Thus, the embodiment described with reference to FIGS. 18
and 19 includes a spring member which gradually increases the
overall volume of the interior chamber 44 as a tip 30 of a separate
device 26 is inserted into the septum 124 of a vascular access
device 10. The spring member 126 may, in other embodiments, take
any form, shape, or size. For example, in one embodiment, the
spring member may be a bistable spring as mentioned earlier. When
actuated by a Luer or other tip 30 of an external or separate
device 26, a bistable spring member will rapidly change shape, or
otherwise buckle, in order to create or increase the overall volume
of the interior chamber 44. Subsequently, when the tip 30 of a
device 10 is removed, the bistable spring will rapidly resume its
posture to its original position, causing the chamber beneath it to
collapse and the overall volume of the interior chamber 44 to
decrease.
[0081] Referring now to FIG. 20, a septum 136 of a vascular access
device 10 includes a knob 138 attached to a metal clip 140 that
rotates or otherwise pivots upon a pin 142. FIG. 20 shows a
vascular access device 10 that is not yet engaged or is disengaged
with a separate device 26. FIG. 20A shows the vascular access
device 10 as engaged with a separate device 26. In FIG. 20A the tip
30 of the separate device 26 is fully inserted into the septum 136
causing the metal clip 140 to rotate in a counter clockwise
direction 144 around the pin 142. The counter clockwise rotation of
the metal clip 140 causes the metal clip 140 to raise the knob 138,
thus creating an increased volume 146 within an interior chamber
44. When the separate device 26 is later removed, the metal clip
140 which is placed on a pre-loaded spring, restores the base, or
diaphragm, 148 of the septum 136 to its original position. When the
base 148 is returned to its original position, the internal fluid
volume of the interior chamber 44 is decreased, causing fluid to
flow from the extravascular system (to which the device 10 and
separate device 26 are attached) to the vascular system of a
patient.
[0082] Referring now collectively to FIGS. 21 through 23, a
vascular access device 10 includes a septum 150 with a slit 152 and
at least one clearance slot 154 through which at least one spring
finger 156 may articulate. The septum 150 includes a reservoir 158
at its base. An annular structure 160 may include at least one
spring finger 156. The annular structure 160 includes a lumen
through which the septum 150 may be placed.
[0083] Referring now to FIG. 24, a cross-section of the vascular
access device 10 of FIG. 21 is shown engaged with the septum 150 of
FIG. 22 and the annular member 160 of FIG. 23. The combination of
the body 20 of the vascular access device 10, the septum 150, and
the annular member 160 is shown in resting position, prior to
access by the tip 30 of a separate device 26. In its resting state,
the spring fingers 156 of the annular member 160 force the septum
150 closed, which in turn causes the reservoir 158 to be
compressed. When the reservoir 158 is compressed, an interior
chamber 44 has a relatively smaller internal volume.
[0084] Referring now to FIG. 25, the vascular access device 10 of
FIG. 24 is shown fully engaged with the separate device 26 such
that the tip 30 is fully inserted into the septum 150. Upon full
insertion, the tip 30 causes the spring fingers 156 to separate
outwards through the clearance slots 154 which are shown in FIG.
21. With the spring fingers 156 extending outwards through the
clearance slots 154, the base or bottom of the septum 150 has more
room to expand just above the reservoir 158. When the base of the
septum 150 expands just above the reservoir 158, the reservoir also
expands causing an increased amount of volume within the interior
chamber 44. Subsequently, when the tip 30 is removed from the
device 10, the spring fingers 156 will move inwardly from the
clearance slots 154 towards the septum 150, causing the septum 150
to close the body of the septum 150 to compress upon the reservoir
158 and the reservoir to collapse to its original starting position
as shown in FIG. 24. This action of moving the reservoir 158 from a
decompressed to a compressed state will cause the internal volume
of the interior chamber 44 to decrease, which in turn causes fluid
to flow from the interior chamber 44 through the extravascular
system and into the vascular system of a patient. This flow of
fluid will prevent any unwanted reflux of blood or other fluid from
a patient's vascular system into the extravascular system.
[0085] Referring now to FIG. 26, a vascular access device 10
includes a body 20 and an elastomeric slit septum 162. A split
wedge 164 resides within a lower chamber 44 of the septum 162. The
split wedge is capable of separating its bottom angled surface when
coerced by the tip 30 of a separate device 26 against a rigid base
member 166 that resides beneath the split wedge 164. Referring now
to FIG. 27, the vascular access device 10 of FIG. 26 is shown with
the tip 30 of a separate device 26 fully engaged within the septum
162. When the tip 30 places force upon the top surface 168 of the
split wedge 164, the bottom angled surfaces 170 of the split wedge
164 are pressed against the surface of the rigid structure 166,
causing the split wedge 164 to separate. When the split wedge 164
separates, the elastic walls of the septum 162 also separate
causing the internal volume of the interior chamber 44 to increase.
The internal volume of the interior chamber 44 increases both
between the legs of the split wedge 164 and on the sides of the
rigid structure 166.
[0086] Referring now to FIG. 28, a vascular access device 10
includes a septum 172 with a slit 174 and at least one curved,
rigid, pivoting member 176. The pivoting members 176 are fixed to a
pivot point 178 against the body 20 of the vascular access device
10.
[0087] Referring now to FIG. 29, the vascular access device 10 of
FIG. 28 is shown with the tip 30 of a separate device 26 fully
engaged with the septum 172. When the tip 30 is fully inserted into
the slit 174, the pivoting members 176 that are embedded within the
septum 172 are forced outward against the walls of the body 20 of
the device 10. In their outward position, the pivoting curved
members 176 open to increase the amount of internal volume within
the interior chamber 44 beneath the closure of the septum 172. The
space 180 that is created during tip 30 insertion is later
eliminated when the tip 30 is removed from the device 10. As this
volume is eliminated, the fluid residing therein is forced from the
extravascular system toward the vascular system of a patient.
[0088] Referring now to FIG. 30, the vascular access device 10
includes a septum 22 and a four-bar mechanism 182 that is separate
and resides on an exterior surface of and in communication with the
septum 22. The four-bar mechanism 182 is anchored to the outer wall
of the body 20 of the device 11.
[0089] Referring now to FIG. 31, the vascular access device 10 of
FIG. 30 is shown with the tip 30 of a separate device 26 inserted
into the septum 22. With normal slit septums that do not include a
four-bar mechanism as that shown in FIGS. 30 and 31, when a tip 30
is inserted into a slit septum, only that portion of the septum
that is in direct contact with the tip is biased open with a
minimal amount of material of the septum 22 in front of the end of
the tip 30. However, the four-bar mechanism 182 of FIG. 31 permits
the septum 22 to open along its entire length when the tip 30 is
initially inserted into the top portion of the septum 22. As the
four-bar mechanism 182 opens the entire length of the septum 22, a
volume 184 is created within the septum 22 as the tip 30 is
initially advanced. The increased volume 184 is added to the volume
beneath it in the extravascular system, and when the tip 30 is
removed from the device 10, the four-bar mechanism 182 collapses
causing the volume 184 to be eliminated. When the volume 184 is
eliminated, fluid is expelled from that volume through the
extravascular system and into the vascular system of a patient.
[0090] Referring now to FIG. 32, a vascular access device 10
includes a septum 22 and a rigid member 186 capable of being
displaced by an air pressure chamber 188 that may be disturbed when
the tip 30 of a separate device 26 is inserted into the septum 22.
The rigid member 186 may be a bistable spring capable of flexing in
alternating directions under the influence of opposing force
exerted upon the body of the spring.
[0091] As the tip 30 is inserted into the septum 22, an upper
chamber 190 decreases in size, forcing air through a channel 192 in
the septum 22, to an air pressure chamber 188 neighboring the rigid
member 186. As the pressure within a neighboring chamber 188
increases, the bistable spring of the rigid member 186 will flex in
a direction 194 into an expansion chamber 196. As the rigid member
186 flexes in a direction 194, the vacuum existing in the
neighboring chamber 188 will pull an internal wall 198 in the
direction 194, causing the volume of an interior chamber 44 to
increase.
[0092] As the tip 30 is retracted from the septum 22, the upper
chamber 190 will increase in size, pulling air from air pressure
chamber 188 through the channel 192 into the upper chamber 190. As
the pressure within the air pressure chamber 188 decreases, the
bistable spring of the rigid member 186 will flex in a direction
opposite direction 194 to return to its original position, causing
the internal wall 198 to also return to its original position, and
causing the volume of the interior chamber 44 to decrease to its
original volume prior to tip 30 insertion. The stress placed upon
the bistable spring is such that only minimal force or pressure is
required to engage the bistable spring in either direction.
[0093] The present invention may be embodied in other specific
forms without departing from its structures, methods, or other
essential characteristics as broadly described herein and claimed
hereinafter. The described embodiments are to be considered in all
respects only as illustrative, and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims,
rather than by the foregoing description. All changes that come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *